Mode rnaTX, Inc.
Form 483 issued September 21, 2023 · Norwood, Massachusetts
- Inspection
- Sep 21, 2023
- Investigator
- Thai D. Truong
- Observations
- 5
- Pages
- 6
- FEI number
- 3014937058
In short: On September 21, 2023, FDA issued a Form 483 with 5 observations to Mode rnaTX, Inc. in Norwood, Massachusetts (FEI 3014937058) after an inspection that ran Sep 21, 2023. The investigator was Thai D. Truong. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
4 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment utilized for drug substance manufacturing are not cleaned properly…
- 02
Cleaning Validation studies of non-dedicated manufacturing equipment did not include challenges with actual conditions used in…
- 03
Separate or defined areas to prevent mix-ups are deficient. Your firm failed to discard or move…
- 04
Written procedures were not…
This inspection in context
Thai D. Truong
12 documents · 2022–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmMode rnaTX, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mode rnaTX, Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Mode rnaTX, Inc.?
Thai D. Truong is named on this Form 483, for the inspection of Sep 21, 2023. Each investigator has a profile showing what they cite most.
When was Mode rnaTX, Inc. inspected by FDA?
The inspection ran Sep 21, 2023, and the Form 483 is dated September 21, 2023.
How do I get the full Form 483 for Mode rnaTX, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.